Parecoxib in Renal Colic
Phase 3
Terminated
- Conditions
- Colic
- Registration Number
- NCT00139646
- Lead Sponsor
- Pfizer
- Brief Summary
This is a phase III, multicenter, randomized, single blind study designed to evaluate the efficacy and tolerability of a single dose of parecoxib compared with diclofenac in the treatment of acute pain due to renal colic.
- Detailed Description
This study was prematurely discontinued May 3, 2004 due to slow recruitment. The decision to terminate the trial was not based on any safety concerns.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- diagnosis of renal colic;
- baseline pain > 50 mm on VAS;
Exclusion Criteria
- evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness;
- active GI disease (e.g. Crohn's disease or ulcerative colitis) or any evidence of concomitant disease which may lead to early termination of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluation of efficacy through: time to onset of pain relief and time to remedication.
- Secondary Outcome Measures
Name Time Method Evaluation of efficacy through: Pain Intensity (VAS), Pain Relief (PR) and several measurements of analgesia that will be derived from VAS and PR Physician's Global Evaluation at 12 hours Patient's Global Evaluation at 12 hours
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇮🇹Siena, Italy